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Reproductive Techniques, AssistedNCT05442125

First Live Birth Rate With eSET After Preimplantation Methylome Screening (PIMS) Versus Conventional In-vitro Fertilization

A study testing Using DNA methylome to select embryos and Using morphologic score to select embryos in people with Reproductive Techniques, Assisted and DNA Methylation, run by Shandong University at 28 sites in 2 countries.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial summary

To determine whether using DNA methylome to select embryos can increase the live birth rate. Read more about this study

Who is it for?
Ages 20 years and older, women onlyHealthy volunteers can take part
What is being tested?
Using DNA methylome to select embryos and Using morphologic score to select embryos
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,146 participants
Where
28 sitesin 2 countries
Study dates
16 Sep 2022to 31 May 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 years and older
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Women who plan to undergo IVF/ICSI/PGT-A treatment.
  • Women aged 20 years and older.
  • Women who obtain 2 or more good-quality blastocysts that defined as morphological score of inner cell mass B or A, trophectoderm C or better, and grade 4 or better on Day 5 of embryo culture.

Who cannot join

  • 4.2 Exclusion Criteria
  • Women with a uterine cavity abnormality, such as a uterine congenital malformation (uterus unicornate, bicornate, or duplex); untreated uterine septum, submucous myoma, or endometrial polyp(s); or with history of intrauterine adhesions.
  • Women who are indicated and planned to undergo preimplantation genetic testing for structural rearrangements (PGT-SR) or preimplantation genetic testing for monogenic (PGT-M).
  • Women who use donated oocytes or sperm to achieve pregnancy;
  • Women with contraindication for assisted reproductive technology or for pregnancy, such as poorly controlled Type I or Type II diabetes; undiagnosed liver disease or dysfunction (based on serum liver enzyme testing); renal disease or abnormal serum renal function; significant anemia; history of deep venous thrombosis, pulmonary embolus, or cerebrovascular accident; uncontrolled hypertension, known symptomatic heart disease; history of or suspected cervical carcinoma, endometrial carcinoma, or breast carcinoma; undiagnosed vaginal bleeding.

Trial locations and contacts

28 sites in 2 countries.

Yuan Gao, Professor contact

0531-86569866

gaoyuan@sduivf.com

28 sites in 2 countries

China27 sites, 27 recruiting

  • Center for Reproductive Medicine, Center for Prenatal Diagnosis First Hospital, Jilin University

    Changchun

    Ruizhi Liu, Professor

    Recruiting

  • Clinical Research Center for Reproduction and Genetics in Hunan Province, Reproductive and Genetic Hospital of CITIC-XIANGYA

    Changsha, 410008

    Lin Ge, Professor

    Recruiting

  • 900 th Hospital of Joint Logistics Support Force

    Fuzhou

    Yun Liu, Professor

    Recruiting

  • Fujian Maternity and Child Health Hospital College of Clinical Medicine for Obstetrics & Gynecology and Pediatrics, Fujian Medical University

    Fuzhou

    Beihong Zhen, Professor

    Recruiting

  • Guangzhou Womenand Children's Medical Center

    Guanzhou

    Ling Sun, Professor

    Recruiting

  • The Sixth Affiliated Hospital of Sun Yat-sen University

    Guanzhou

    Haitao Zeng, Professor

    Not yet recruiting

  • Center for Reproductive Medicine, The Affiliated Hospital of Guizhou Medical University

    Guiyang

    Shunyun Zhao, Professor

    Recruiting

  • The first affiliated hospital of Hainan Medical University

    Haikou

    Yanlin Ma, Professor

    Recruiting

  • Assisted Reproduction Unit, Sir Run Run Shaw Hospital, Zhejiang University School of Medicine

    Hangzhou

    Songying Zhang, Professor

    Recruiting

  • The First Affiliated Hospital of Anhui Medical University

    Hefei

    Yunxia Cao, Professor

    Recruiting

  • Shandong University

    Jinan, Shandong

    Zi-Jiang Chen, Professor, +0086 531 85651190, chenzijiang@vip.163.com

    Yuan Gao, Professor, +0086 531 86569866, gaoyuan@sduivf.com

    Recruiting

  • Center for Reproductive Medicine, Shandong University

    Jinan, 250012

    Yuan Gao, Professor

    Recruiting

  • Affiliated Hospital of Jining Medical University

    Jining

    Aijun Yang, Professor

    Recruiting

  • Liuzhou Hospital of Guangzhou Women and Children's Medical Center

    Liuzhou

    Li Fan, Professor

    Recruiting

  • Department of Reproductive Medicine, Women's Hospital of Nanjing Medical University, Nanjing Maternity and Child Health Care Hospital

    Nanjing

    Xiufeng Ling, Professor

    Recruiting

  • The First Affiliated Hospital with Nanjing Medical University

    Nanjing

    Xiang Ma, Professor

    Recruiting

  • Center for Reproductive Medicine, Ren Ji Hospital, School of Medicine,Shanghai Jiao Tong University

    Shanghai, 200135

    Yun Sun, Professor

    Recruiting

  • Changhai Hospital

    Shanghai

    Hongli Yan, Professor

    Not yet recruiting

  • International Peace Maternity and Child Health Hospital, School of Medicine, Shanghai Jiao Tong University

    Shanghai

    Wen Li, Professor

    Not yet recruiting

  • Reproductive Medical Center of Ruijin Hospital, School of Medicine,Shanghai Jiao Tong University

    Shanghai

    Aijun Zhang, Professor

    Not yet recruiting

  • Shanghai Ji Ai Genetics and IVF Institute, Obstetrics and Gynecology Hospital, Fudan University

    Shanghai

    Xiaoxi Sun, Professor

    Not yet recruiting

  • Shenzhen Maternity & Child Healthcare Hospital

    Shenzhen

    Xuemei Li, Professor

    Recruiting

  • The Second Hospital of Hebei Medical University

    Shijiazhuang

    Guimin Hao, Professor

    Recruiting

  • Center for reproduction and genetics,suzhou municipal hospital

    Suzhou

    Hong Li, Professor

    Recruiting

  • The General Hospital of Ningxia Medical University

    Yinchuan

    Junli Zhao, Professor

    Recruiting

  • Department of Reproductive Medicine, the Third Affiliated Hospital of Zhengzhou University

    Zhengzhou

    Yichun Guan, Professor

    Recruiting

  • Reproductive Medical Center, Henan Provincial People's Hospital

    Zhengzhou

    Cuilian Zhang, Professor

    Recruiting

Other trials in China

Thailand1 site, 1 recruiting

  • Siriraj hospital, Mahidol university

    Bangkok

    Isarin Thanaboonyawat, Doctor

    Not yet recruiting

Other trials in Thailand

About this study

Official title: Whether Using DNA Methylome to Select Embryos Can Increase the Live Birth Rate During Assisted Reproductive Technology: A Multicenter, Randomized , Open-label Clinical Trial.

To determine whether using DNA methylome to select embryos can increase the live birth rate.

Read the detailed description

The rationale for the study is to establish the risk/benefit ratio of PIMS in women with in vitro fertilization (IVF) treatment, as DNA methylome is a potential biomarker in blastocyst selection in assited reproductive technology (ART). DNA methylation plays an important role during embryogenesis, global abnormal methylome reprogramming often occurs in human embryos, and DNA methylome pattern is associated with live birth rate. However, there is still no technology using DNA methylome as an indicator in preimplantation embryo screening. Recent paper reported that using Pre-implantation Methylome Screening (PIMS) can select embryos with better methylation state and euploid chromosomes. The efficiency of PIMS needs further validation through randomized clinical trial.

Being tested
Using DNA methylome to select embryos, Using morphologic score to select embryos
Medical subject headings
Helping Behavior

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Using DNA methylome to select embryosOther

    DNA methylation level Embryo with methylation level closest to the optimal level (from one couple patients) is the one for embryonic transfer to uterus

  • Using morphologic score to select embryosOther

    blastocyst will transferred according to morphologic score or blastocysts will be biopsied on trophectoderm, sequenced with next-generation sequencing (NGS). Euploidy will transferred one by one according to morphologic score.

Study groups in NCT05442125
Study groupRoleWhat they receive
PIMS groupExperimentalCouples in the PIMS group will have up to 6 blastocysts screened with PIMS and a single euploid embryo with the optimal state of whole-genome DNA methylation and the highest morphologic score will be selected for the initial transfer. The optimal state of whole-genome DNA methylation includes methylation level closest to the optimal level (0.26 according to our preliminary results) and proper methylation state for some specific regions.
Receives: Other: Using DNA methylome to select embryos
Conventional-IVF groupActive comparatorFor women between 20 and 37 years of age,couples in the conventional-IVF group will have a single best blastocyst by morphologic criteria selected for the initial transfer.For women over 37 years old, couples in the PGT-A group will have up to 6 blastocysts tested with PGT-A and a single euploid embryo with the highest morphologic score will be selected for the initial transfer.
Receives: Other: Using morphologic score to select embryos

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. live birth rate of initial embryo transfer

    Live birth rate is defined as delivery of any viable infant at 28 weeks or more of gestation, after initial embryo transfer in women using the embryos selected through PIMS or PGT-A or morphological criteria alone.

    Measured: 22 months

Secondary outcomes (8)

  1. Good Birth Outcome rate

    Defined as a live birth of an infant born at ≥ 37 weeks, with a birth weigh between 2500 and 4000g and without a major congenital anomaly

    Measured: 36 months

  2. Clinical pregnancy rate

    Twenty days after conception, transvaginal ultrasonography will be performed. Clinical pregnancy will be diagnosed with detection of an intrauterine gestational sac.

    Measured: 36 months

  3. Pregnancy loss rate

    Number of pregnancy losses / number of clinical pregnancies after transfer.

    Measured: 36 months

  4. Multiple pregnancy rate

    Number of multiple pregnancy/number of clinical pregnancies after transfer.

    Measured: 36 months

  5. Duration of pregnancy

    Duration of pregnancy is the period between conception and birth.

    Measured: 36 months

  6. Birth weight

    Weight of newborns at delivery.

    Measured: 36 months

  7. Maternal complications

    Number of pregnancies with complications / number of pregnancies.

    Measured: 48 months

  8. Neonatal complications

    Number of live births with neonatal complications / number of live births.

    Measured: 48 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Jul 2022
  2. Study start16 Sep 2022
  3. Primary completion1 Jun 2024 (estimated)
  4. Study completion31 May 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
1,146 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05442125
Sponsor's protocol ID
PIMS-IVF
Status last verified
Jan 2024
First submitted
28 Jun 2022
Last updated
18 Jan 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Brezina PR, Kutteh WH. Clinical applications of preimplantation genetic testing. BMJ. 2015 Feb 19;350:g7611. doi: 10.1136/bmj.g7611.

    PubMed 25697663

  • Hassold T, Chen N, Funkhouser J, Jooss T, Manuel B, Matsuura J, Matsuyama A, Wilson C, Yamane JA, Jacobs PA. A cytogenetic study of 1000 spontaneous abortions. Ann Hum Genet. 1980 Oct;44(2):151-78. doi: 10.1111/j.1469-1809.1980.tb00955.x.

    PubMed 7316468

  • Dahdouh EM, Balayla J, Audibert F; Genetics Committee; Wilson RD, Audibert F, Brock JA, Campagnolo C, Carroll J, Chong K, Gagnon A, Johnson JA, MacDonald W, Okun N, Pastuck M, Vallee-Pouliot K. RETIRED: Technical Update: Preimplantation Genetic Diagnosis and Screening. J Obstet Gynaecol Can. 2015 May;37(5):451-63. doi: 10.1016/s1701-2163(15)30261-9.

    PubMed 26168107

  • Kalousek DK, Pantzar T, Tsai M, Paradice B. Early spontaneous abortion: morphologic and karyotypic findings in 3,912 cases. Birth Defects Orig Artic Ser. 1993;29(1):53-61. No abstract available.

    PubMed 8280893

  • Rubio C, Bellver J, Rodrigo L, Castillon G, Guillen A, Vidal C, Giles J, Ferrando M, Cabanillas S, Remohi J, Pellicer A, Simon C. In vitro fertilization with preimplantation genetic diagnosis for aneuploidies in advanced maternal age: a randomized, controlled study. Fertil Steril. 2017 May;107(5):1122-1129. doi: 10.1016/j.fertnstert.2017.03.011. Epub 2017 Apr 19.

    PubMed 28433371

  • Sacchi L, Albani E, Cesana A, Smeraldi A, Parini V, Fabiani M, Poli M, Capalbo A, Levi-Setti PE. Preimplantation Genetic Testing for Aneuploidy Improves Clinical, Gestational, and Neonatal Outcomes in Advanced Maternal Age Patients Without Compromising Cumulative Live-Birth Rate. J Assist Reprod Genet. 2019 Dec;36(12):2493-2504. doi: 10.1007/s10815-019-01609-4. Epub 2019 Nov 12.

    PubMed 31713776

  • Yan J, Qin Y, Zhao H, Sun Y, Gong F, Li R, Sun X, Ling X, Li H, Hao C, Tan J, Yang J, Zhu Y, Liu F, Chen D, Wei D, Lu J, Ni T, Zhou W, Wu K, Gao Y, Shi Y, Lu Y, Zhang T, Wu W, Ma X, Ma H, Fu J, Zhang J, Meng Q, Zhang H, Legro RS, Chen ZJ. Live Birth with or without Preimplantation Genetic Testing for Aneuploidy. N Engl J Med. 2021 Nov 25;385(22):2047-2058. doi: 10.1056/NEJMoa2103613.

    PubMed 34818479

  • Smith ZD, Meissner A. DNA methylation: roles in mammalian development. Nat Rev Genet. 2013 Mar;14(3):204-20. doi: 10.1038/nrg3354. Epub 2013 Feb 12.

    PubMed 23400093

  • Jones PA. Functions of DNA methylation: islands, start sites, gene bodies and beyond. Nat Rev Genet. 2012 May 29;13(7):484-92. doi: 10.1038/nrg3230.

    PubMed 22641018

  • Jiang L, Zhang J, Wang JJ, Wang L, Zhang L, Li G, Yang X, Ma X, Sun X, Cai J, Zhang J, Huang X, Yu M, Wang X, Liu F, Wu CI, He C, Zhang B, Ci W, Liu J. Sperm, but not oocyte, DNA methylome is inherited by zebrafish early embryos. Cell. 2013 May 9;153(4):773-84. doi: 10.1016/j.cell.2013.04.041.

    PubMed 23663777

  • Li G, Yu Y, Fan Y, Li C, Xu X, Duan J, Li R, Kang X, Ma X, Chen X, Ke Y, Yan J, Lian Y, Liu P, Zhao Y, Zhao H, Chen Y, Sun X, Liu J, Qiao J, Liu J. Genome wide abnormal DNA methylome of human blastocyst in assisted reproductive technology. J Genet Genomics. 2017 Oct 20;44(10):475-481. doi: 10.1016/j.jgg.2017.09.001. Epub 2017 Sep 6.

    PubMed 29037989

  • Hardarson T, Van Landuyt L, Jones G. The blastocyst. Hum Reprod. 2012 Aug;27 Suppl 1:i72-91. doi: 10.1093/humrep/des230. Epub 2012 Jul 3. No abstract available.

    PubMed 22763375

  • Schieve LA, Meikle SF, Peterson HB, Jeng G, Burnett NM, Wilcox LS. Does assisted hatching pose a risk for monozygotic twinning in pregnancies conceived through in vitro fertilization? Fertil Steril. 2000 Aug;74(2):288-94. doi: 10.1016/s0015-0282(00)00602-6.

    PubMed 10927046

  • Fiorentino F, Biricik A, Bono S, Spizzichino L, Cotroneo E, Cottone G, Kokocinski F, Michel CE. Development and validation of a next-generation sequencing-based protocol for 24-chromosome aneuploidy screening of embryos. Fertil Steril. 2014 May;101(5):1375-82. doi: 10.1016/j.fertnstert.2014.01.051. Epub 2014 Mar 6.

    PubMed 24613537

Questions about this trial

What is this clinical trial studying?

A study testing Using DNA methylome to select embryos and Using morphologic score to select embryos in people with Reproductive Techniques, Assisted and DNA Methylation, run by Shandong University at 28 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 18 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 28 sites in China, Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Yuan Gao, Professor (0531-86569866, gaoyuan@sduivf.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

live birth rate of initial embryo transfer (time frame: 22 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05442125, which also lists 14 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2024.

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